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Penlac Solution is used for:

Treating mild to moderate toenail or fingernail fungus.

Penlac Solution is an antifungal agent. It is believed to work by slowing the growth of fungi.

Do NOT use Penlac Solution if:

• you are allergic to any ingredient in Penlac Solution
• you are taking an oral antifungal medicine, for a fungal infection of the fingernail or toenail

Contact your doctor or health care provider right away if any of these apply to you.

Before using Penlac Solution:

Some medical conditions may interact with Penlac Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have diabetes

Some MEDICINES MAY INTERACT with Penlac Solution. However, no specific interactions with Penlac Solution are known at this time.

Ask your health care provider if Penlac Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Penlac Solution:

Use Penlac Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Apply this medication evenly over the entire nail plate once daily and a small amount of the surrounding skin, preferably at bedtime or 8 hours before washing. If possible, apply this medication to the nail bed and under the surface of the nail plate.
• Do not remove this medication on a daily basis. Daily applications of this medication should be made over the previous coat and removed every 7 days with alcohol.
• Using an emery board, file away any loose nail material, and trim nails every 7 days after this medication is removed with alcohol.
• This medication may need to be taken for up to 48 weeks in combination with nail removal done by your health care provider to achieve a clear or almost clear nail. It may take up to 6 months to see any noticeable improvement in your nail. However, a completely clear nail may not be achieved with the use of this medication.
• To clear up your infection completely, use Penlac Solution for the full course of treatment.
• If you miss a dose of Penlac Solution and you are using it daily at bedtime, skip the missed dose. Do not use the medicine the following morning. If you do not use the dose at bedtime and you miss a dose, use it as soon as possible. If several hours have passed or it is nearing time for the next dose, skip the missed dose and return to your regular dosing schedule.

Ask your health care provider any questions you may have about how to use Penlac Solution.

Important safety information:

• For use on nails and surrounding skin only. Do not get Penlac Solution in your eyes, nose, or mouth. If you get it in your eyes, rinse right away with cool tap water.
• Penlac Solution may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.
• Do not use nail polish or other nail cosmetic products while using this medication.
• Do not use this medication near heat or open flame because this medication is flammable.
• PREGNANCY AND BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Penlac Solution while you are pregnant. It is not known if Penlac Solution is found in breast. If you are or will be breast-feeding while you use Penlac Solution, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Penlac Solution:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Change in shape of nail; discoloration; ingrown toenail; irritation; redness of the treated area.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blistering; burning; increased redness; itching; oozing of the treated area; rash on the palms; swelling.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Penlac Solution may be harmful if swallowed.

Store Penlac Solution at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Protect from light. Keep away from heat and flame. Keep Penlac Solution out of the reach of children and away from pets.

General information:

• If you have any questions about Penlac Solution, please talk with your doctor, pharmacist, or other health care provider.
• Penlac Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Penlac Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.